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Completed

NCT Number: NCT03006445

Study of FYU-981 in Hyperuricemia With or Without Gout

The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and ascending dose regimen.

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Key information

Conditions

Hyperuricemia With or Without Gout

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hyperuricemic or gout patients
  • Serum urate level:

>= 7.0mg/dL in patients with history of gout, or >= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL

Exclusion criteria

  • Gouty arthritis within two weeks before start of study treatment
  • Secondary hyperuricemia
  • HbA1c: >= 8.4%
  • Uric acid-overproduction type in the classification of hyperuricemia
  • History of, clinically significant cardiac, hematologic and hepatic disease
  • Kidney calculi or clinically significant urinary calculi
  • eGFR: < 30mL/min/1.73m^2
  • Systolic blood pressure: >= 180 mmHg
  • Diastolic blood pressure: >= 110 mmHg

Treatment and study plan

FYU-981

Drug

Primary outcomes

  1. Percent reduction from baseline in serum urate level at the final visit

    Time frame: 34 or 58 weeks

Sponsors and collaborators

Lead sponsor

Fuji Yakuhin Co., Ltd.

Industry

Collaborators

  • Mochida Pharmaceutical Company, Ltd.

Registry information

Official study title

Official Title: Safety and Efficacy Evaluation Study of FYU-981 Long-term Administration for Hyperuricemia With or Without Gout (Phase III Study)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 30, 2016
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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